enGen Laboratory Automation System (Product Code ENGEN) configured with Thermo Scientific Centrifuge Module and TCAutomation Software Version 3.6.1 and Below; IVD. --- Thermo Scientific Centrifuge Module has Product Code 952040-EG 6844097. The VITROS 5,1 FS Chemistry System with enGen Laboratory Aut
Check against the official notice below — it lists the full affected range.
Ortho-Clinical Diagnostics is recalling its enGen Laboratory Automation System (Product Code ENGEN) with Thermo Scientific Centrifuge Module and TCAutomation Software Version 3.6.1 and below due to a potential error in the centrifuge module that can cause sample identification to be mixed up with assay results. This mis-association of samples and results could allow incorrect assay results to be reported to patients before the system detects the error, potentially leading to inappropriate medical treatment and serious patient injury. The recall affects 60 devices worldwide, including 24 in the United States.
The affected devices are identified by specific software versions (3.6.1 and below) and serial numbers listed in the recall record. The systems have been distributed nationwide in the United States and to Belgium, Bermuda, Canada, Chile, Denmark, France, Italy, Mexico, Norway, Portugal, Sweden, Taiwan, and the United Kingdom. The source document does not specify what remedy affected consumers should pursue.
Written by software from the official notice below. Not reviewed by a lawyer.
Ortho confirmed that it is possible for the mis-association of sample identification and assay results due to an error with Thermo Fishers centrifuge module. It is possible for mis-associated assay results to be reported from the laboratory prior to the identification of the Cross Check error on the enGen Laboratory Automation System. Assay results associated with the wrong patient and reported out of the laboratory could lead to inappropriate intervention with the potential for serious injury to the patient.
Reason for recall: Ortho confirmed that it is possible for the mis-association of sample identification and assay results due to an error with Thermo Fishers centrifuge module. It is possible for mis-associated assay results to be reported from the laboratory prior to the identification of the Cross Check error on the enGen Laboratory Automation System. Assay results associated with the wrong patient and reported out of the laboratory could lead to inappropriate intervention with the potential for serious injury to the patient. Distribution: Worldwide Distribution-(Nationwide) and foreign distribution to the following countries: Belgium, Bermuda, Canada, Chile, Denmark, France, Italy, Mexico, Norway, Portugal, Sweden, Taiwan and United Kingdom. Quantity: 60 (US: 24; Foreign: 36) Lot/code info: Software Versions 3.6.1 and below; Affected US Serial Numbers: 5GV6W2J,GBX395J, J2QKG25J, 2Z3YV1J, 3RHC23J, 4HX7S4J, 54FC01J, 5J4B45J, 736BM4J, 7KSC15J, J86PWC5J, 953209, 953221, 953266, 953270, B3ZHP2J, CXL941J, JFBX395J, FCM073J, FXCBG3J, JG7BFB5J, GWXQ52J, HJ5K84J, HPKG25J -- Affected Foreign Serial Numbers: DWXO52J, GWJZY4J, J16XQH4J, BGV6W2J, 17QP94J, 4SHPF4J, 1K5K84J, 37QP34J, H5PWC5J, J2V6LW4J, F6MXR3J, JT6LW4J, N0551107, F1150698, 46XQH4J, 2S5OP0J, CRKM82, J41BCY4J, J56T205J, BGV6W2J, 7YCF43J, 96XQHAJ, C1JNZ5J, C3JTP4J, D3JTP4J, 86T205J, 18BFB5J, 96PWC5J, 1LSSF5J, 4drj44j, 8W7WG3J, J953222, J953244, JCT20Q3J, HWJZY4J, 38769917923.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.